Evaluate the Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia After Chemotherapy in Patients With Non-Hodgkin's Lymphoma

Not Applicable

• Conditions: Non Hodgkin's Lymphoma
• Interventions: Drug: PEG-rhG-CSF

• Registration Number: NCT04497688
• Lead Sponsor: CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

Brief Summary

The main treatments for non-Hodgkin's lymphoma are surgery, radiotherapy, chemotherapy, and bone marrow transplantation. Neutropenia is the most common and serious complication of most chemotherapy. This study is a multi-center, open-label, single-arm clinical study to evaluate the efficacy and safety of jinyouli in preventing neutropenia in patients with non Hodgkin's lymphoma after chemotherapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-27
• Study First Submitted QC: 2020-08-02
• Last Update Submitted: 2020-08-02
• Study First Posted: 2020-08-04
• Last Update Posted: 2020-08-04
• Primary Completion: 2020-09-01
• Study Completion: 2020-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

1. Age ≥ 18 years, gender is not limited;
2. Patients with lymphoma diagnosed by histopathology or cytology;
3. Patients requiring multi-cycle chemotherapy;
4. Planned chemotherapy regimen FN risk ≥ 20 % , or 10% <FN risk < 20% with high risk factors ; According to the judgment of the investigator, there is a risk of FN occurrence if G-CSF support is not accepted, PEG-rhG-CSF should be used prophylactically from the first cycle;
5. Physical status (KPS) score ≥ 70 points;
6. Expected Survival period of more than 3 months;
7. Normal bone marrow hematopoietic function (ANC ≥1.5×10^9/L, PLT≥80×10^9/L, Hb≥75g/L, WBC≥3.0×10^9/L);
8. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5 times the upper limit of normal value, or≤5 times the upper limit of normal value when there is liver metastasis; total bilirubin (TBIL)≤2.5 times the upper limit of normal value; serum creatinine (Cr)≤2 times the upper limit of normal value;
9. Female patients of childbearing age must be negative in urine pregnancy test before treatment;
10. The testers (or their legal representatives/guardians) must sign an informed consent form.

Exclusion Criteria

1. Lymphoma central involvement;
2. Hematopoietic stem cell transplantation or organ transplantation;
3. Local or systemic infection without adequate control;
4. Severe internal organ dysfunction and occurred in the last 6 months Myocardial infarction;
5. Those who used other test drugs of the same kind or accepted other clinical trials within 4 weeks before enrollmen；
6. Allergy to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed by Escherichia coli;
7. Severe mental illness, affecting informed consent and/or adverse reaction expression or observation;
8. Pregnant or lactating female patients; women who refuse to accept contraceptive measures ;
9. Researchers determine unsuited to participate in this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEG-rhG-CSF group	PEG-rhG-CSF	Patients received subcutaneous injection of PEG-rhG-CSF(Jinyouli®) 48 hours after the end of chemotherapy, 6mg for patients with body weight≥45kg and 3mg for patients with body weight less than 45kg, once per chemotherapy cycle

Primary Outcome Measures

Name	Time	Method
The incidence of grade Ⅲ/Ⅳ neutropenia	From date of randomization until the date of the study completion，up to 24 weeks	Grade Ⅲ neutropenia is defined as ANC≥0.5×10\^9/L, and \<1×10\^9/L; Grade Ⅳ neutropenia is defined as ANC\<0.5×10\^9/L

Secondary Outcome Measures

Name	Time	Method
Incidence of febrile neutropenia (FN)	From date of randomization until the date of the study completion，up to 24 weeks	A single oral temperature is 38.3℃ or ≥38℃ for more than 1 h, and the absolute value of neutrophils is less than 0.5×10\^9/L or the absolute value of neutrophils is less than 1.0×10\^9/L but it is expected to drop to less than 0.5×10\^9/L within 48 hours
Antibiotic use rate	From date of randomization until the date of the study completion，up to 24 weeks	Antibiotic use rate during the treatment cycle
Incidence of dose adjustment of chemotherapy or delay of chemotherapy	From date of randomization until the date of the study completion，up to 24 weeks	Dose adjustment is defined as the reduction of planned dose of chemotherapy; Chemotherapy delay is defined as the delay in starting the next planned chemotherapy for more than 3 days.

Trial Locations

Locations (1)

The fourth hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China